Emergent Biodefense Operations Lansing LLC

Form 483 issued October 26, 2000 · Lansing, Michigan

Inspection: Nov 15, 1999 – Oct 26, 2000
Investigators: Cynthia L. Kelley· Julia Lukas Garman
Observations: 30
Pages: 26
FEI number: 1873886

In short: On October 26, 2000, FDA issued a Form 483 with 30 observations to Emergent Biodefense Operations Lansing LLC in Lansing, Michigan (FEI 1873886) after an inspection that ran Nov 15, 1999 – Oct 26, 2000. The investigators were Cynthia L. Kelley and Julia Lukas Garman. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).

At a glance

18 of 30 observations on this 483 concern production.

Production18

Quality system5

Facilities & equipment5

Laboratory controls2

Most cited: 21 CFR 211.113 (12×) · 211.192 (6×)

What FDA observed

Preview: the opening words of each observation

Dashed: section inferred by FDA Intel and checked against the regulation text

01
21 CFR 211.100
Observation 1: scanned text, readable in the full document.
02
21 CFR 211.160
Regarding assays used for in-process control and further processing decisions…
03
21 CFR 211.113
The holding time for the following sterilized equipment has not been…
04
21 CFR 211.113
Regarding validation of aseptic operations in Bldg 12: a) The challenges did not include incubation of…

26 more observations

Plus the full detail behind each one, exactly as FDA wrote it.

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This inspection in context

The investigator

Cynthia L. Kelley

1 document · 2000

Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Michigan.

The firm

Emergent Biodefense Operations Lansing LLC history

All 11 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other sites cited under 211.113

See how FDA wrote the same problem up elsewhere.

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Form 483 from this inspectionOct 26, 2000$99

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Questions about this 483

What did FDA find at Emergent Biodefense Operations Lansing LLC?

FDA listed 30 observations on this Form 483, mostly about production, quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.

Who inspected Emergent Biodefense Operations Lansing LLC?

Cynthia L. Kelley and Julia Lukas Garman are named on this Form 483, for the inspection of Nov 15, 1999 – Oct 26, 2000. Each investigator has a profile showing what they cite most.

When was Emergent Biodefense Operations Lansing LLC inspected by FDA?

The inspection ran Nov 15, 1999 – Oct 26, 2000, and the Form 483 is dated October 26, 2000.

How do I get the full Form 483 for Emergent Biodefense Operations Lansing LLC?

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